Ignite Creation Date:
2025-12-18 @ 9:44 AM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT06597513
Status:
None
Last Update Posted:
2024-10-15 00:00:00
First Post:
2024-09-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC
Sponsor:
None
Organization:
Study Overview
Official Title:
A Single-Arm Trial of Hematopoietic Stem Cell Transplantation-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer
Status:
None
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach.
The main questions it aims to answer are:
Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment?
Participants will:
Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization.
Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles.
If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles.
Finally, participants may enter a maintenance phase with adebrelimab.
Throughout the trial, participants will:
Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months
The main questions it aims to answer are:
Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment?
Participants will:
Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization.
Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles.
If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles.
Finally, participants may enter a maintenance phase with adebrelimab.
Throughout the trial, participants will:
Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: